Albany Molecular Research, Inc (AMRI) announced the initiation of its phase-I study of ALB109564(a), a novel tubulin inhibitor, which is designed to kill cancer cells by preventing cell mitosis.
The study will be conducted at four clinical trial sites for a period of nine to twelve months and include up to 40 subjects. The drug will be administered intravenously to cancer patients with advanced solid tumours in an ascending dose study to evaluate the compound's safety, tolerability and pharmacokinetic profile.
This announcement marks the second compound from AMRI's internally funded R&D portfolio to advance into phase-I clinical testing, following on the recent announcement of the submission of a Canadian Clinical Trial Application (CTA) by Bristol-Myers Squibb (BMS) for a compound licensed by BMS from AMRI's central nervous system research program.
"We are pleased to begin the process of enrolling patients and commencing phase-I clinical trials of our compound and are hopeful that this first clinical step will ultimately lead to a new weapon in the fight against cancer," said AMRI chairman, president and CEO Thomas E D'Ambra. "The initiation of this study demonstrates the company's ability to leverage its full spectrum of scientific capabilities to generate new products with commercial potential and to execute on the R&D portion of our strategic plan to provide value to stakeholders."
ALB109564(a) is a novel analog from an established and marketed class of tubulin inhibitors, which is designed to kill cancer cells by preventing cell mitosis. ALB 109564(a) is a cytotoxic agent and a semi-synthetic derivative of a natural product originally extracted from the Madagascar periwinkle flower.
Founded in 1991, Albany Molecular Research, Inc (AMRI) provides scientific services, products and technologies focused on improving the quality of life. AMRI works on drug discovery and development projects and conducts manufacturing of active ingredients and pharmaceutical intermediates for many of the world's leading healthcare companies.